Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-31 @ 1:22 AM
Study NCT ID:
NCT07307703
Status:
RECRUITING
Last Update Posted:
2025-12-29
First Post:
2025-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TENS for Anxiety, Pain, and Satisfaction After Laparoscopic Cholecystectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002769', 'term': 'Cholelithiasis'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004561', 'term': 'Transcutaneous Electric Nerve Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'No additional parties are masked in this study. Due to the nature of the intervention (TENS), participants and care providers are aware of group allocation. The study is conducted as an open-label randomized controlled trial.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study uses a parallel assignment model. Participants undergoing elective laparoscopic cholecystectomy will be randomly assigned to one of two groups:\n\nIntervention group: Patients will receive Transcutaneous Electrical Nerve Stimulation (TENS) in addition to standard perioperative care.\n\nControl group: Patients will receive standard perioperative care without TENS.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-15', 'studyFirstSubmitDate': '2025-12-10', 'studyFirstSubmitQcDate': '2025-12-15', 'lastUpdatePostDateStruct': {'date': '2025-12-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative Pain Intensity (VAS)', 'timeFrame': 'Within the first 24 hours after surgery', 'description': 'Pain intensity will be assessed using the Visual Analog Scale (VAS), a validated 10 cm scale ranging from 0 (no pain) to 10 (worst imaginable pain). Patients will be asked to mark their pain level at specified postoperative intervals. The primary analysis will compare mean pain scores between the TENS group and the control group to determine whether TENS reduces postoperative pain following laparoscopic cholecystectomy.'}, {'measure': 'Postoperative Pain Intensity', 'timeFrame': 'Within the first 24 hours after surgery', 'description': 'Pain intensity will be assessed using the Visual Analog Scale (VAS), a validated 10 cm scale ranging from 0 (no pain) to 10 (worst imaginable pain). Patients will be asked to mark their pain level at specified postoperative intervals. The primary analysis will compare mean pain scores between the TENS group and the control group to determine whether TENS reduces postoperative pain following laparoscopic cholecystectomy.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Laparoscopic Cholecystectomy', 'Gallstone Disease', 'Surgical Anxiety', 'Postoperative Pain', 'Transcutaneous Electrical Nerve Stimulation (TENS)'], 'conditions': ['Gallstone Disease', 'Postoperative Pain', 'Surgical Anxiety', 'Patient Satisfaction After Laparoscopic Cholecystectomy']}, 'descriptionModule': {'briefSummary': 'This study is designed to evaluate whether Transcutaneous Electrical Nerve Stimulation (TENS) can improve recovery for patients undergoing laparoscopic gallbladder removal surgery (laparoscopic cholecystectomy). TENS is a non-invasive method that uses mild electrical currents applied through the skin to stimulate nerves.\n\nThe main goals of the study are to determine if TENS can:\n\nReduce surgical anxiety before and during the procedure\n\nDecrease postoperative pain after surgery\n\nImprove overall patient satisfaction with their surgical experience\n\nPatients who participate will receive standard surgical care, and some will also receive TENS therapy. Outcomes will be measured using patient questionnaires and clinical assessments during the hospital stay and follow-up period.\n\nBy comparing patients who receive TENS with those who do not, the study aims to provide evidence on whether this simple technique can enhance comfort and recovery after gallbladder surgery.', 'detailedDescription': 'Gallstone disease is common in Western countries, and cholecystectomy is a routine abdominal surgical procedure. The laparoscopic approach is considered the gold standard. However, many patients experience acute postoperative pain, often reported as moderate to severe. Acute pain delays recovery and may lead to complications.\n\nOpioids remain the cornerstone of postoperative pain management, but they are associated with adverse effects such as sedation, nausea, respiratory depression, and opioid-induced hyperalgesia. In addition, long-term problematic opioid use has been reported in 6-8% of patients after surgery. Therefore, non-pharmacological alternatives for postoperative pain relief are urgently needed.\n\nTranscutaneous Electrical Nerve Stimulation (TENS) is a non-invasive intervention that delivers electrical currents through electrodes placed on intact skin. Evidence from systematic reviews and meta-analyses suggests that TENS is effective and safe for managing both acute and chronic pain, with minimal side effects and low cost. Patients may experience mild tingling or discomfort, and rarely skin irritation.\n\nDespite promising data, few studies have evaluated the combined effects of TENS on surgical anxiety, postoperative pain, and patient satisfaction in laparoscopic cholecystectomy. Most prior research has focused only on pain outcomes, neglecting psychological dimensions and patient-centered measures. This study aims to fill that gap by assessing whether TENS can reduce perioperative anxiety, improve pain control, and enhance satisfaction with surgical care.\n\nThis randomized controlled trial will be conducted at Adana City Training and Research Hospital between October 2025 and October 2026. Eligible patients undergoing elective laparoscopic cholecystectomy will be randomized into two groups: a TENS intervention group and a control group receiving standard care. The sample size was determined by power analysis, requiring 40 participants per group (total n=80).\n\nData collection will include:\n\nPersonal Information Form (demographics and baseline characteristics)\n\nVisual Analog Scale (VAS) for pain intensity\n\nSurgery-Specific Anxiety Scale (validated Turkish instrument)\n\nNewcastle Satisfaction with Nursing Care Scale (validated Turkish version)\n\nExclusion criteria include emergency cholecystectomy, conversion to open surgery, presence of pacemakers or implanted devices, uncontrolled epilepsy, chronic opioid use, severe psychiatric or cognitive disorders, dermatological contraindications, or concurrent participation in another clinical trial.\n\nThe primary outcomes are surgical anxiety, postoperative pain, and patient satisfaction. Secondary outcomes include recovery parameters and adverse events.\n\nHypotheses:\n\nNull hypothesis (H0): TENS has no effect on surgical anxiety, postoperative pain, or patient satisfaction in laparoscopic cholecystectomy.\n\nAlternative hypothesis (H1): TENS reduces surgical anxiety and postoperative pain while increasing patient satisfaction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18-65 years scheduled for elective laparoscopic cholecystectomy\n\nASA (American Society of Anesthesiologists) physical status classification I-II\n\nAbility to understand the study procedures and provide written informed consent\n\nNo contraindications to TENS application (e.g., intact skin at electrode placement sites)\n\nWillingness to comply with perioperative assessments (pain, anxiety, satisfaction scales)\n\nExclusion Criteria:\n\n* Patients with ASA III or higher physical status\n\nPresence of cardiac pacemaker or other implanted electrical devices\n\nHistory of epilepsy, severe neuropathy, or psychiatric disorders affecting pain/anxiety perception\n\nSkin lesions, infections, or dermatological conditions at electrode placement sites\n\nUse of analgesics, anxiolytics, or sedatives beyond standard perioperative protocols\n\nEmergency cholecystectomy or conversion to open surgery\n\nPregnant or breastfeeding women\n\nPatients unwilling or unable to provide informed consent'}, 'identificationModule': {'nctId': 'NCT07307703', 'acronym': 'TENS-LC', 'briefTitle': 'TENS for Anxiety, Pain, and Satisfaction After Laparoscopic Cholecystectomy', 'organization': {'class': 'OTHER', 'fullName': 'Nigde Omer Halisdemir University'}, 'officialTitle': 'Effects of Transcutaneous Electrical Nerve Stimulation (TENS) on Surgical Anxiety, Postoperative Pain, and Patient Satisfaction in Patients Undergoing Laparoscopic Cholecystectomy', 'orgStudyIdInfo': {'id': '22504254-050.04Cholecystectomy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1 TENS Group', 'description': 'Participants in this arm will receive Transcutaneous Electrical Nerve Stimulation (TENS) in addition to standard perioperative care for laparoscopic cholecystectomy. TENS will be applied using surface electrodes placed on intact skin before and after surgery. The stimulation parameters will follow established clinical guidelines to ensure safety and effectiveness. Outcomes assessed include surgical anxiety, postoperative pain intensity, and patient satisfaction.', 'interventionNames': ['Device: Transcutaneous Electrical Nerve Stimulation (TENS)']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Participants in this arm will receive standard perioperative care for laparoscopic cholecystectomy without Transcutaneous Electrical Nerve Stimulation (TENS). Usual surgical and nursing protocols will be followed according to hospital standards. Outcomes assessed include surgical anxiety, postoperative pain intensity, and patient satisfaction, which will be compared with the intervention group to evaluate the added effect of TENS.'}], 'interventions': [{'name': 'Transcutaneous Electrical Nerve Stimulation (TENS)', 'type': 'DEVICE', 'otherNames': ['TENS Therapy', 'Electrical Nerve Stimulation'], 'description': 'Transcutaneous Electrical Nerve Stimulation (TENS) is a non-invasive device-based intervention that delivers mild electrical currents through electrodes placed on intact skin. In this study, TENS will be applied perioperatively to patients undergoing laparoscopic cholecystectomy. The stimulation sessions will be conducted before and after surgery, following standardized clinical parameters to ensure safety and reproducibility. The intervention is designed to evaluate its effects on surgical anxiety, postoperative pain intensity, and patient satisfaction compared with standard care.', 'armGroupLabels': ['Arm 1 TENS Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '51100', 'city': 'Niğde', 'state': 'Adana', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Abdurrahman acar', 'role': 'CONTACT', 'email': 'a.car7272@hotmail.com', 'phone': '+905415298930'}, {'name': 'Kezban Koraş SÖZEN, Associate Professor', 'role': 'CONTACT', 'email': 'kezbankoras@ohu.edu.tr', 'phone': '+90, 0543 805 62 09'}], 'facility': 'Adana City Hospital'}], 'centralContacts': [{'name': 'Kezban Koraş SÖZEN, Associate Professor', 'role': 'CONTACT', 'email': 'kezbankoras@ohu.edu.tr', 'phone': '+90, 0543 805 62 09'}, {'name': 'Abdurrahman ACAR, Research Assistant', 'role': 'CONTACT', 'email': 'aacar@ohu.edu.tr', 'phone': '+90, 0541 529 89 30'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data (IPD) will not be shared because the study involves a limited sample size and is conducted at a single institution. Ethical considerations and institutional policies restrict the sharing of raw patient-level data. Only aggregated results will be reported in publications.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nigde Omer Halisdemir University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant, Faculty of Health Sciences, Niğde Ömer Halisdemir University', 'investigatorFullName': 'Abdurrahman Acar', 'investigatorAffiliation': 'Nigde Omer Halisdemir University'}}}}